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Clinical Trials/CTRI/2023/09/057916
CTRI/2023/09/057916Not yet recruitingPhase 3 4

A Pilot study examining the Neurobiological correlates of Virechanakarma in Patients with Major Depressive Disorder

Centre For Excellence, AYUSH1 site in 1 country40 target enrollmentStarted: September 27, 2023Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
To examine the baseline Cardiac Autonomic Function & Neurohemodynamic

Study Overview

Brief Summary

Depression is the most common psychiatric disorder in the world population and the most

frequent mental disorder in a primary health care. Depressive disorders are characterized by

sadness, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or

appetite, feelings of tiredness, and poor concentration. Major depressive disorder (MDD) is

analogous to a disease condition described in Ayurveda as Vishada. Vishada is a condition

characterized by global reduction in activities of mind, sensory faculties and body arising out of

disequilibria in doshas. Vishada has been mentioned as an extraordinary disease of the vata.

Ayurveda literature has dealt with the disease and its management comprehensively. Clinically

apart from vata dosa , involvement of kapha & pitha are also seen in patients of Major depressive

disorders like reduced energy levels , increased fatiguability , loss of appetite , diurnal variation

of worsening in morning hours ,dullness , withdrawal , disgust , anxiety etc,. In the combination

of tridosa, kapha need to be addressed first, then pitha and then vata. For kaphapitha hara

virechana is the best sodhana therapy advised as per Ayurveda literature. Recent study

demonstrates a positive influence of ayurvedic therapy on psychopathology, cardiac autonomic

function and endocrinal parameters in patients with depression. Clinically, we have found

considerable improvement in mood symptoms after a course of sodhana therapy. Sodhana can be

an adjunct in treating mood disorders. No published literature on efficacy of virechana in Mood

disorders are there, despite being classically recommended in texts. Neurobiological correlates of

virechanakarma in neuropsychiatric disorders is not studied making it a novel effort. Hence, this

study aims to understand the neurobiological correlates of virechanakarma in patients with

MDD.

It is a randomised control trial study which will assess changes in clinical parameters, cardiac

autonomic function(HRV), neurohemodynamic parameters(fNIRS), physiological

parameters(CRP , S.Cortisol) and metabolic parameters(FBS & Lipid profile) after the

intervention.

Study Design

Study Type
Interventional
Allocation
Permuted block randomization, fixed
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Between 18 to 60 years of age.
  • All genders.
  • Diagnosed case of unipolar depression as per DSM 5
  • Patients who have not responded (Subjective improvement less than 50% / HDRS scale less than 50% reduction in score / CGI – severity score more than or equal to 4 or CGI global improvement score at the end of 4 weeks is more than or equal to 3) to 4 weeks of first Antidepressant trial.
  • Patients suitable for Virechana
  • Willing to give informed consent.

Exclusion Criteria

  • Patients who are on Tricyclic Antidepressants
  • Patients with any co -morbid axis I psychiatry disorders (except for nicotine dependence syndrome), major systemic illness, neurological disorders and immune systemdisorders
  • Patients with active suicidal tendencies / attempts or uncooperative for assessments and procedure
  • Pregnant and lactating mothers
  • Patients unsuitable for Virechana procedure
  • Patients with uncontrolled diabetes mellitus, hypertension, severe hepatic, renal or pulmonary dysfunction
  • Patients who have undergone Virechana in the last 1 month.

Outcomes

Primary Outcomes

To examine the baseline Cardiac Autonomic Function & Neurohemodynamic

Time Frame: Baseline, 2 weeks

parameters in patients with MDD in comparison to Healthy people by measuring

Time Frame: Baseline, 2 weeks

HRV & fNIRS of Dorsolateral Prefrontal Cortex.

Time Frame: Baseline, 2 weeks

• To examine the change in Cardiac Autonomic Function & Neurohemodynamic

Time Frame: Baseline, 2 weeks

parameters following add-on virechanakarma in patients with MDD in comparison

Time Frame: Baseline, 2 weeks

to Treatment As Usual Group (TAU)

Time Frame: Baseline, 2 weeks

Secondary Outcomes

  • To examine the clinical effects of add-on virechanakarma in patients with MDD in(comparison to Treatment As Usual Group (TAU).)

Investigators

Sponsor
Centre For Excellence, AYUSH
Sponsor Class
Government funding agency

Study Sites (1)

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